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Cardiovascular

28,927 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
EXPRESS AND EXPRESS2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS (P020009/S005)Boston Scientific Scimed, Inc.2003-01-24
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A) (P880086/S091)ABBOTT MEDICAL2003-01-22
PASSIVE PLUS DX, MODELS 1336T, 1342T, 1343K, 1345K, 1346T (P960030/S009)ABBOTT MEDICAL2003-01-22
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A) (P830045/S083)St. Jude Medical, Inc.2003-01-22
EASYTRAK LEAD MODELS 4510, 4511, 4512 AND 4513 CORONARY VENOUS STEROID ELUTING SINGLE-ELECTRODE PACE/SENSE LEADS (P010012/S003)Boston Scientific Corp2003-01-22
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A) (P900070/S028)St. Jude Medical, Cardiac Rhythm Management Divisi2003-01-22
TENDRIL DX, MODELS 1388 T/K & TENDRIL SDX MODELS 1488 T/K (P960013/S012)ABBOTT MEDICAL2003-01-22
RIATA SERIES DEFIBRILLATION LEAD SYSTEM (P950022/S015)ABBOTT MEDICAL2003-01-22
AV PLUS DX, MODEL 1368 (P880086/S090)ABBOTT MEDICAL2003-01-22
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A) (P910023/S063)ABBOTT MEDICAL2003-01-22
EXPRESS AND EXPRESS2 CORONARY STENT SYSTEMS (P020009/S004)Boston Scientific Scimed, Inc.2003-01-22
GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S013)Guidant Corp.2003-01-21
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S014)Boston Scientific Scimed, Inc.2003-01-17
WALLSTENT (TIPS,ILAC,VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S005)Boston Scientific Corporation2003-01-17
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S016)Boston Scientific Corp2003-01-17
GALILEO/GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S015)Guidant Corp.2003-01-17
CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS (P010041/S001)Edwards Lifesciences, LLC2003-01-17
AMPLATZER SEPTAL OCCLUDER AND AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS (P000039/S003)ABBOTT MEDICAL2003-01-15
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S006)Boston Scientific Corp2003-01-14
NOVACOR N100PC LVAS WITH OPTIONAL EPTFE INFLOW CONDUIT (P980012/S003)Worldheart, Inc.2003-01-10
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S015)Boston Scientific Corp2003-01-10
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S013)Boston Scientific Scimed, Inc.2003-01-10
WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S004)Boston Scientific Corporation2003-01-10
MEDTRONIC ENHANCER ABLATION CATHETERS (P930029/S019)Medtronic, Inc.2003-01-08
NOVOSTE BETA-CATH SYSTEM (P000018/S025)Best Vascular, Inc.2003-01-06
MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) PRODUCT (P900061/S054)Medtronic Cardiac Rhythm Disease Management2003-01-06
ANCURE ENDOGRAFT SYSTEM (P990017/S037)Boston Scientific Corp2003-01-02
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS (P870077/S014)Edwards Lifesciences, LLC2002-12-31
THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S024)Thoratec Laboratories Corp.2002-12-31
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS (P010041/S003)Edwards Lifesciences, LLC2002-12-31
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S020)Edwards Lifesciences, LLC2002-12-31
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S016)Edwards Lifesciences, LLC2002-12-31
FINISHING WIRE UNIVERSAL (P010012/S005)Boston Scientific Corp2002-12-30
ANEURX STENT GRAFT SYSTEM (P990020/S010)Medtronic Vascular2002-12-23
ATTAIN OTW 4193 LEFT VENTRICULAR PACING LEAD (P010015/S007)Medtronic, Inc.2002-12-23
CARDIOSEAL SEPTAL OCCLUSION SYSTEM W/QWIK LOAD (P000049/S007)Nmt Medical, Inc.2002-12-23
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P000009/S006)Biotronik, Inc.2002-12-20
ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM (P930038/S034)Terumo Medical Corporation2002-12-20
PROTOS FAMILY OF PULSE GENERATORS (P950037/S029)Biotronik, Inc.2002-12-20
ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM (P930038/S035)Terumo Medical Corporation2002-12-20
PERMANENT PACEMAKER ELECTRODE (P820076/S023)Biotronik, Inc.2002-12-20
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD'S) (P980023/S011)Biotronik, Inc.2002-12-20
SUTURE TRIMMER FOR THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM (P960043/S043)Abbott Vascular, Inc.2002-12-20
BELOS DR AND BELOS DR-T DUAL-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS (P000009/S005)Biotronik, Inc.2002-12-20
CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P010012/S002)Boston Scientific Corp2002-12-20
MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM (P020007)Medtronic Vascular2002-12-18
TALENT II DUAL-SENSOR IMPLANTABLE CARDIAC PACEMAKERS, MODELS DR233 AND SR133 (P950029/S016)MicroPort CRM USA, Inc.2002-12-18
QWIKSTAR DIAGNOSTIC/ABLATION CATHETERS (MODELS D-1229 AND D-1230) AND QWIKSTAR INTERFACE CABLE (MODEL D-1195-12) (P990025/S004)Biosense Webster, Inc.2002-12-18
NC BIG RANGER PTCA CATHETER (P860019/S192)Scimed Life Systems, Inc.2002-12-17
GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S014)Guidant Corp.2002-12-17
MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE (P930029/S018)Medtronic, Inc.2002-12-17
MEDTRONIC MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS WITH (P980016/S029)Medtronic Cardiac Rhythm Disease Management2002-12-17
VENTAK P2 LEADS AND ACCESSORIES (P930035/S010)Boston Scientific2002-12-13
RES-Q ACCESSORIES (P940008/S017)Boston Scientific2002-12-13
ENDOTAK/ENDURANCE/RELIANCE LEADS AND ACCESSORIES (P910073/S040)Boston Scientific2002-12-13
SELUTE LEADS AND ACCESSORIES (P950001/S009)Boston Scientific2002-12-13
VENTAK PRX LEADS AND ACCESSORIES (P910077/S038)Boston Scientific2002-12-13
SWEETIP RX/SWEET PICOTIP RX/FLEXTEND (P960006/S007)Boston Scientific2002-12-13
CONTAK CD/EASYTRAK LEADS & ACCESSORIES (P010012/S006)Boston Scientific Corp2002-12-13
VENTAK LEADS AND ACCESSORIES (P830060/S051)Boston Scientific2002-12-13
THINLINE/FINELINE LEADS AND ACCESSORIES (P960004/S021)Boston Scientific2002-12-13
GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS (P000052/S009)Guidant Corp.2002-12-10
CARBOMEDICS CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS (P900060/S024)Corcym S.r.l.2002-12-10
DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEMS (P970035/S041)Medtronic, Ireland2002-12-06
PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE (P950037/S028)Biotronik, Inc.2002-12-06
CARDIOGENESIS TMR2000 HOLMIUM LASER SYSTEM (P970029/S006)Cryolife, Inc.2002-12-03
QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM (P010049/S003)Sub-Q, Inc.2002-11-27
ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08) (P990069)Dot Medical Products , Ltd.2002-11-27
KAINOX RV-S/ KAINOX VCS ICD LEADS (P980023/S009)Biotronik, Inc.2002-11-25
BOSTON SCIENTIFIC ACE/TRAPPER/SURPASS/REMEDY PTCA CATHETERS (P860019/S190)Scimed Life Systems, Inc.2002-11-25
RADIUS CORONARY STENT W/DELIVERY SYSTEM (P970061/S018)Boston Scientific Scimed, Inc.2002-11-25
THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM (P990020/S009)Medtronic Vascular2002-11-21
MAVERICK OTW, MAVERICK MONORAIL & MAVERICK2 MONORAIL PTCA CATHETERS (P860019/S186)Scimed Life Systems, Inc.2002-11-21
MAVERICK 2 MONORAIL PTCA CATHETERS (P860019/S179)Scimed Life Systems, Inc.2002-11-20
GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM (P000052/S012)Guidant Corp.2002-11-18
BIODIVYSIO OC/SV OTW STENT DELIVERY SYSTEMS (P000011/S007)Abbott Vascular, Inc.2002-11-14
NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER (P950005/S015)Biosense Webster, Inc.2002-11-13
NAVISTAR DEFLECTABLE TIP DIAGNOSTIC/ABLATION CATHETER (P990025/S005)Biosense Webster, Inc.2002-11-13
NOVOSTE BETA-CATH 3.5F SYSTEM (P000018/S026)Best Vascular, Inc.2002-11-13
PERCLOSE A-T 6 FR. SUTURE MEDICATED CLOSURE (SMC) SYSTEM (P960043/S042)Abbott Vascular, Inc.2002-11-12
ANCURE SYSTEM (P990017/S036)Boston Scientific Corp2002-11-08
THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS) (P920014/S016)Thoratec Corp2002-11-06
EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004)W. L. Gore & Associates, Inc.2002-11-06
NC MONORAIL/NC BIG RANGER/NC RANGER PTCA CATHETHERS (P860019/S189)Scimed Life Systems, Inc.2002-11-06
EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM (P020009/S002)Boston Scientific Scimed, Inc.2002-11-05
OMNICARBON CARDIAC VALVE PROSTHESIS (P830039/S011)Medical Cv, Inc.2002-10-29
THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S022)Thoratec Laboratories Corp.2002-10-29
RADIUS CORONARY STENT AND DELIVERY CATHETER (P970061/S017)Boston Scientific Scimed, Inc.2002-10-29
HANCOCK II PORCINE BIOPROSTHESIS MODEL T505 (AORTIC) (P980043/S002)Medtronic, Inc.2002-10-28
MEDTRONIC AVE S7 ZIPPER MX CORONARY STENT SYSTEM (P970035/S043)Medtronic, Ireland2002-10-28
MOSAIC PORCINE BIOPROSTHESIS MODEL 305 (AORTIC) (P990064/S007)Medtronic, Inc.2002-10-28
MEDTRONIC INSYNC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODEL 7272 (P010031/S001)Medtronic Cardiac Rhythm Disease Management2002-10-25
BETA-CATH XL DELIVERY CATHETER - 60 MM (P000018/S021)Best Vascular, Inc.2002-10-25
MAVERICK XL PTCA CATHETER (MONORAIL) (P860019/S183)Scimed Life Systems, Inc.2002-10-24
MAVERICK OTW/RANGER PTCA CATHETERS (P860019/S188)Scimed Life Systems, Inc.2002-10-24
ANEURX STENT GRAFT SYSTEM (P990020/S011)Medtronic Vascular2002-10-24
PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P860019/S187)Scimed Life Systems, Inc.2002-10-23
MEDTRONIC MODEL 7272 INSYNC ICD (P010031/S002)Medtronic Cardiac Rhythm Disease Management2002-10-23
ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS (P810046/S213)Advanced Cardiovascular Systems, Inc.2002-10-23
PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P980001/S041)Boston Scientific Corp2002-10-23
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